FDA.reportPublic FDA data

NDC 0781-7249-06 - BUPRENORPHINE AND NALOXONE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0781-7249
Requested NDC
0781-7249-06
Package NDCs from labels
0781-7249-06, 0781-7249-64
Manufacturer
Indivior Inc.
Effective date
2021-04-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BUPRENORPHINE AND NALOXONE - Indivior Inc.Indivior Inc.2021-04-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7249-06EA - Each0781-72491bb36689-3c63-4b20-b327-05bc578f533712019-10-07
0781-7249-64EA - Each0781-7249064c1984-7eb1-4e07-8102-b7b4b7aeabae12019-03-12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEMajor Pharmaceuticalsc5fbec69-e7de-44a8-b9fa-0378ae61a9fe2026-03-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Incbd65e3fe-cd7a-4855-8f55-8cc3a0921ccc2026-03-02Warnings, Adverse reactionsExact identifier
unii: F850569PQR
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma442831cf-9636-433a-9a12-e9a8cd31f72a2026-02-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmad5b011ef-f1be-47f2-8f8b-07553f36193c2026-02-28Warnings, Adverse reactionsExact identifier
unii: F850569PQR
unii: 56W8MW3EN1
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERedpharm Drug300ae3d0-464c-d0be-e063-6294a90a7f9d2026-02-21Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEUnit Dose Solutions, Inc.4b301ad7-ac0e-f849-e063-6394a90a27d52026-02-19Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINESun Pharmaceutical Industries, Inc.9fd1f18f-0b0f-4059-b603-19ecbf0ed63a2026-02-11Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEREMEDYREPACK INC.68df290c-d776-4cfc-9565-332eb56c47232026-02-10Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONESun Pharmaceutical Industries, Inc.91b68606-05de-4586-ae31-07e8cc9160cf2026-02-10Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
naloxone hydrochlorideNALOXONE HYDROCHLORIDELifestar Pharma LLCaef6719c-cd71-46ee-b7b1-1806b939bf3e2026-02-09Warnings, Adverse reactionsExact identifier
unii: F850569PQR
BUPRENORPHINEBUPRENORPHINEA-S Medication Solutionsbfb02ea5-22f2-432e-afc8-f1dbe2ea06142026-02-06Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEActavis Pharma, Inc.6cccf229-9611-4b6f-8f1b-acc8ff1ed3f82026-02-06Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEAmneal Pharmaceuticals LLC17b63f10-c9df-44be-80fa-6f1c305583b82026-02-02Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.221195e4-de08-414c-af08-a611a74789de2026-01-30Warnings, Adverse reactionsExact identifier
unii: F850569PQR
unii: 56W8MW3EN1
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.5ab2d4e4-3c8c-413a-b147-23eafbde313a2026-01-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEHikma Pharmaceuticals USA Inc.1bf8b35a-b769-465c-a2f8-099868dfcd2f2026-01-24Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.